Wet Age Related Macular Degeneration
Conditions
Keywords
wet AMD, macular degeneration, ranibizumab, mono-bilateral, poor visual acuity, retinal disease, eye disease, Angiogenesis Inhibitors, Angiogenesis Modulating Agents
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).
Interventions
DRUGranibizumab
All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab
Exclusion criteria
Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Systemic Drug-related Adverse Events | Baseline to Month 12 | Monitoring and recording all adverse events, including serious adverse events. |
| Number of Eyes With Ocular Drug-related Adverse Events | Baseline to Month 12 | Monitoring and recording all adverse events, including serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Number of Ranibizumab Injections | Baseline to month 12 | — |
| Time Interval Between Injections in Bilateral Disease | Baseline to month 12 | Mean number of days between two consecutive injections per eye |
| Mean Number of Injections Per Patient | Baseline to month 12 | Number of injections per patient |
Countries
Italy
Participant flow
Recruitment details
Patients were recruited from investigative sites located in Italy.
Pre-assignment details
This reporting group includes all treated patients (one eye or both eyes)
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab patients treated with 0.5mg ranibizumab | 936 |
| Total | 936 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 11 |
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 38 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Unsatisfactory therapeutic effect | 24 |
| Overall Study | Withdrawal by Subject | 76 |
Baseline characteristics
| Characteristic | Ranibizumab |
|---|---|
| Age, Continuous | 78.68 years STANDARD_DEVIATION 7.34 |
| Age, Customized 18 to less than 65 years | 33 Participants |
| Age, Customized 65 to 74 years | 212 Participants |
| Age, Customized 75 to 84 years | 483 Participants |
| Age, Customized 85 years and older | 208 Participants |
| Sex: Female, Male Female | 582 Participants |
| Sex: Female, Male Male | 354 Participants |
| Treatment by Eye Bilateral treatment | 113 Participants |
| Treatment by Eye Unilateral treatment | 823 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 936 |
| other Total, other adverse events | 76 / 936 |
| serious Total, serious adverse events | 63 / 936 |
Outcome results
Primary
Number of Eyes With Ocular Drug-related Adverse Events
Monitoring and recording all adverse events, including serious adverse events.
Time frame: Baseline to Month 12
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Eyes With Ocular Drug-related Adverse Events | Serious Adverse Event | 1 eyes |
| Ranibizumab | Number of Eyes With Ocular Drug-related Adverse Events | Non Serious Adverse Event | 8 eyes |
Primary
Number of Participants With Systemic Drug-related Adverse Events
Monitoring and recording all adverse events, including serious adverse events.
Time frame: Baseline to Month 12
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Systemic Drug-related Adverse Events | Serious Adverse Event | 3 participants |
| Ranibizumab | Number of Participants With Systemic Drug-related Adverse Events | Non Serious Adverse Event | 0 participants |
Secondary
Mean Number of Injections Per Patient
Number of injections per patient
Time frame: Baseline to month 12
Population: Safety set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Mean Number of Injections Per Patient | 5.97 injections | Standard Deviation 3.62 |
| Unilaterally Treted | Mean Number of Injections Per Patient | 5.35 injections | Standard Deviation 2.88 |
| Bilaterally Treated | Mean Number of Injections Per Patient | 10.55 injections | Standard Deviation 4.98 |
Secondary
Overall Number of Ranibizumab Injections
Time frame: Baseline to month 12
Population: Safety Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Overall Number of Ranibizumab Injections | 5.97 injections per patient | Standard Deviation 3.62 |
Secondary
Time Interval Between Injections in Bilateral Disease
Mean number of days between two consecutive injections per eye
Time frame: Baseline to month 12
Population: This analysis population includes all eyes naïve to ranibizumab, i.e., had not been treated with the study medication (or with the equivalent commercial formulation) before the first study drug injection, regardless of whether the contralateral eye had been treated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Time Interval Between Injections in Bilateral Disease | 51.94 days | Standard Deviation 26.56 |